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Nex for Medtech

NEX: Accelerating Software Development for MedTech

Expedite SaMD Product Delivery
Regulatory Ready
Customizable and Configurable
Device/Biosensor Agnostic
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NEX Platfrom Medtech

Start with a Pre-Built & Regulatory-ready
Software Solution

Reduce development time and accelerate delivery of MVP, clinical, and commercial milestones.

  • A Complete Software Foundation for MedTech

    Customized for you: iOS and Android Companion Apps, Patient and Clinician Dashboards, an Administrator Portal, and a Secure Cloud.

  • Collect, Analyze and Display Real-Time Data in just weeks

    Speed, flexibility, and insight—everything you need to turn data into decisions, faster than ever before.
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Why Choose NEX?

A purpose-built medtech software foundation — delivered faster, owned by you.

Designed for regulated environments

NEX is developed under an ISO 13485–certified QMS and in line with IEC 62304 and ISO 14971. Each deployment includes a subsystem DHF, providing a controlled foundation for regulated medical device software development.

Purpose built for biosensors and connected devices

No need to reinvent the wheel. NEX is designed for physiological monitoring, biosensors, and CGMs, reflecting real-world patterns for device data, clinician workflows, and patient engagement — reducing customization and accelerating delivery.

Built for ownership and control

We build the software. You own the product. NEX is delivered as a complete system and hosted in your environment, giving you full control over your product roadmap, data, architecture, and long-term evolution. NEX adapts to your strategy and workflows, allowing you to move forward without external constraints on how your product grows over time.

Accelerate delivery with a proven medtech partner

By starting from a purpose-built foundation and working with a team experienced in medtech software, companies can avoid years of duplicated effort and reduce development time and cost by up to ~80% compared with building equivalent capabilities from scratch.

NEX platfrom all development stages

One Foundation - Support for All Development Stages

NEX powers every stage of software product development. With our MVP-123 program, launch your companion app or full platform MVP in less than three months.
NEX Architecture Diagram

  • Prototype

    Quickly develop and test prototypes to validate your concepts before full-scale development.

  • MVP

    Develop Minimum Viable Products (MVPs) efficiently to test market readiness and demonstrate your product to investors.

  • Clinical

    Seamlessly transition to developing clinical applications with
    built-in compliance features.

  • Commercial

    Confidently scale up to full commercial applications using our
    reliable prebuilt infrastructure.
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  • Rapid Time to Market

    Prebuilt Mobile Apps, Cloud Dashboards, and Admin Portal: Start with fully functional software. Customized and configured to fit your device's unique requirements.

  • Full Service Software and Support

    Sequenex fast-tracks software delivery with regulatory expertise, end-to-end software engineering, custom development and prebuilt modules, and ongoing support.

  • Regulatory Compliance

    Compliant with regulatory requirements and customizable. NEX includes robust “out of the box” features and functionality and allows for a wide variety of customizations. Start your project at 80% done!

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    Secure & Scalable Cloud Architecture

    HIPAA-Compliant Storage, End-to-End Data Encryption, Real Time Data Processing, Comprehensive Cybersecurity Protocols, Data Back Up and Recovery

  • ISO 13485 Certified QMS

    NEX has been engineered, validated and tested under Sequenex’s ISO 13485 Certified Quality Management System, ensuring adherence to the highest regulatory standards in the industry.

    Comprehensive Documentation

    We provide tailored and required regulatory documentation (DHF, SRS, V&V) to streamline compliance and support your product.

  • Design Controls

    The NEX platform complies with 21 CFR 820.30, IEC 62304 and ISO 14985 ensuring all aspects of the software development process and any modifications are documented and controlled.

    Built-In Compliance Features

    The NEX platform includes features to maintain continuous compliance with industry standards and regulations, including automated data logging, traceability, and audit trails.

Customization and Flexibility

  • Configurable UI and Features

    Easily customize the platform’s user interface and functionalities to suit your specific needs and branding.

  • Adaptable Architecture

    Modify and expand the platform to meet the unique requirements of your device.
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  • Comprehensive Maintenance and Support

  • Expert Support

    Sequenex provides expert support and ensures seamless device integration with the NEX platform — from initial setup to real-time data collection.

  • Maintenance

    Sequenex Engineering can manage and maintain the NEX platform for you, ensuring innovations and updates are seamlessly implemented and fully documented under regulatory guidelines.

  • Lower Development Costs

    Save up to 80% in time and dollars with the NEX Platform. Designed specifically with BLE and NFC connected devices in mind.

  • Efficient Resource Allocation

    Companies can allocate their resources more efficiently, focusing on innovation and device differentiation instead of software development.

  • Cost and Resource Efficiency

Want to schedule a demo of NEX?

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